Percutaneous needle fasciotomy versus limited fasciectomy in Dupuytren's disease
Completed
- Conditions
- Dupuytren's diseaseMusculoskeletal DiseasesFibroblastic disorders
- Registration Number
- ISRCTN58554745
- Lead Sponsor
- niversity Medical Centre Groningen (UMCG) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Patients with Dupuytren?s disease presenting at the Department for Plastic, Reconstructive and Hand Surgery of the Isala Klinieken, Zwolle from August 2002
2. Total passive extension deficit of at least 30° in the metacarpophalangeal (MCP) joint, proximal interphalangeal (PIP) joint and/or distal interphalangeal (PIP) joint
3. Existence of a clearly defined palmar cord
4. Willingness to participate in this trial. Following counselling written consent was obtained from all patients that entered the study
Exclusion Criteria
1. Postsurgical recurrence or extension of the disease
2. Patients who were not allowed to stop their anticoagulants
3. Generally unfit for surgery
4. Patients with a specific treatment modality wish
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Treatment results: Total Passive Extension Deficit (degrees) assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years<br>2. Recurrence: Recurrence was defined as an increase of total passive extension deficit of at least 30 degrees compared to the 6 weeks follow-up values in the area previously treated. At the time of registration patients suffering from recurrent disease and treated for recurrence, are still in follow-up.
- Secondary Outcome Measures
Name Time Method 1. Flexion (Boyes, cm) assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years<br>2. Sensibility (Semmes-Weinstein) assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years<br>3. Complications assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years<br>4. Satisfaction (scale) assessed by questionnaire at 1, 2, 3, 4, 5, 6 weeks, and 6 months, and thereafter yearly until 5 years